Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ELOTUZUMAB (UNII: 1351PE5UGS) (ELOTUZUMAB - UNII:1351PE5UGS)
E.R. Squibb & Sons, L.L.C.
ELOTUZUMAB
ELOTUZUMAB 300 mg
INTRAVENOUS
PRESCRIPTION DRUG
None. There are no available data on EMPLICITI use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. Animal reproduction studies have not been conducted with elotuzumab. EMPLICITI is administered in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone. Lenalidomide and pomalidomide can cause embryo-fetal harm and are contraindicated for use in pregnancy. Refer to the lenalidomide, pomalidomide and dexamethasone prescribing information for additional information. Lenalidomide and pomalidomide are only available through a REMS program. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. There are no data on the presence of EMPLICITI in hum
EMPLICITI (elotuzumab) is white to off-white lyophilized powder available as follows: Carton Content NDC One 300 mg single-dose vial 0003-2291-11 One 400 mg single-dose vial 0003-4522-11 Store EMPLICITI under refrigeration at 2°C to 8°C (36°F-46°F). Protect EMPLICITI from light by storing in the original package until time of use. Do not freeze or shake.
Biologic Licensing Application
EMPLICITI- ELOTUZUMAB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION E.R. SQUIBB & SONS, L.L.C. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE EMPLICITI SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EMPLICITI. EMPLICITI (ELOTUZUMAB) FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2015 INDICATIONS AND USAGE EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in • • DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS For Injection: 300 mg or 400 mg lyophilized powder in a single-dose vial for reconstitution. (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS Most common adverse reactions (20% or higher) • • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BRISTOL-MYERS SQUIBB AT 1-800-721-5072 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. USE IN SPECIFIC POPULATIONS Pregnancy: Embryo-fetal toxicity in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone. (8.1) SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 3/2022 ® combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. (1) combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. (1) With lenalidomide and dexamethasone: 10 mg/kg administered intravenously every week for the first two cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity. (2.1) With pomalidomide and dexamethasone: 10 mg/kg administered intravenously every week for the first two cycles and 20 mg/kg every 4 weeks thereafter until disease progression or unacceptable toxicity. (2.2) Premedicate with dexamethasone, diphenhydramine, ranitidine and acetaminophen. (2.3) Infusion reactions: Premedi Přečtěte si celý dokument